Identity
- Trade Name
- Carrot Broth™ FDA UDI
- Generic Name
- Differential/selective broth culture medium IVD FDA UDI
- Device Name
- Strep B Carrot Broth™ Tiles, for the selective enrichment and identification of beta-hemolytic group B streptococci (S. agalactiae) from clinical specimens. Tiles must be added to broth (not included) upon inoculation. FDA UDI
- Model / Reference
- Z140T FDA UDI
- Description
- Strep B Carrot Broth™ Tiles, for the selective enrichment and identification of beta-hemolytic group B streptococci (S. agalactiae) from clinical specimens. Tiles must be added to broth (not included) upon inoculation. FDA UDI
Identifiers
- Catalog Number
- Z140T FDA UDI
- Primary DI / UDI-DI
- 10819398020579 FDA UDI
- FDA Product Code
- PQZ FDA UDI
- GMDN Term
- Differential/selective broth culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Differential/selective broth culture medium IVD
Carrot Broth™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Differential/selective broth culture medium IVD.
- BD BBL™ Sabouraud Liquid Broth, Modified (Antibiotic Medium 13) — BECTON DICKINSON AND COMPANY · Class I
- REMEL — REMEL, INC. · Class I
- Tryptic Soy Broth 15g/L - 5ml tube — Lonza Verviers · Class I
- REMEL — REMEL, INC. · Class I
- 3% w/v TSB - 50 L bag — Lonza Verviers · Class I
- TSB 3%:1 L bag SAMPLE — Lonza Verviers · Class I
- Tryptic Soy Broth 200L bag — Lonza Verviers · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI 6b74fced-062e-45ea-8501-bf25a4b783ae 36 fields · synced Jun 1, 2026